Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial

Steve Cunningham, Aryelly Rodriguez, Tim Adams, Kathleen A. Boyd, Isabella Butcher, Beth Enderby, Morag Maclean, Jonathan McCormick, James Y. Paton, Fiona Wee, Huw Thomas, Kay Riding, Steve W Turner, Chris Williams, Emma McIntosh, Steff C Lewis

Research output: Contribution to journalArticle

52 Citations (Scopus)
4 Downloads (Pure)

Abstract

Background The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90% for children with bronchiolitis, which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections. No evidence exists to support this threshold. We aimed to assess whether the 90% or higher target for management of oxygen supplementation was equivalent to a normoxic 94% or higher target for infants admitted to hospital with viral bronchiolitis. Methods We did a parallel-group, randomised, controlled, equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK (the Bronchiolitis of Infancy Discharge Study [BIDS]). A central computer randomly allocated (1:1) infants, in varying length blocks of four and six and without stratification, to be clipped to standard oximeters (patients treated with oxygen if pulse oxygen saturation [SpO2] <94%) or modified oximeters (displayed a measured value of 90% as 94%, therefore oxygen not given until SpO2 <90%). All parents, clinical staff, and outcome assessors were masked to allocation. The primary outcome was time to resolution of cough (prespecified equivalence limits of plus or minus 2 days) in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN28405428. Findings Between Oct 3, and March 30, 2012, and Oct 1, and March 29, 2013, we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters. Cough resolved by 15·0 days (median) in both groups (95% CI for difference −1 to 2) and so oxygen thresholds were equivalent. We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group. In the standard care group, eight infants transferred to a high-dependency unit, 23 were readmitted, and one had a prolonged hospital stay. In the modified care group, 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital. Recorded adverse events did not differ significantly. Interpretation Management of infants with bronchiolitis to an oxygen saturation target of 90% or higher is as safe and clinically effective as one of 94% or higher. Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children, particularly in developing nations where resources are scarce. Funding National Institute for Health Research, Health Technology Assessment programme.
Original languageEnglish
Pages (from-to)1041–1048
Number of pages8
JournalThe Lancet
Volume386
Issue number9998
Early online date11 Sep 2015
DOIs
Publication statusPublished - 12 Sep 2015

Fingerprint

Bronchiolitis
Double-Blind Method
Oxygen
Cough
Respiratory Tract Infections
Viral Bronchiolitis
Biomedical Technology Assessment
Hospital Units
Pediatric Hospitals
Developing Countries
Length of Stay
Randomized Controlled Trials
Parents
Pediatrics
Physicians

Keywords

  • bronchiolitis
  • oxygen saturation
  • respiratory infection
  • hypoxemia
  • respiratory syncytial virus

Cite this

Cunningham, S., Rodriguez, A., Adams, T., Boyd, K. A., Butcher, I., Enderby, B., ... Lewis, S. C. (2015). Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial. The Lancet, 386(9998), 1041–1048. https://doi.org/10.1016/S0140-6736(15)00163-4

Oxygen saturation targets in infants with bronchiolitis (BIDS) : a double-blind, randomised, equivalence trial. / Cunningham, Steve ; Rodriguez, Aryelly; Adams, Tim; Boyd, Kathleen A.; Butcher, Isabella; Enderby, Beth; Maclean, Morag; McCormick, Jonathan; Paton, James Y. ; Wee, Fiona; Thomas, Huw; Riding, Kay; Turner, Steve W; Williams, Chris; McIntosh, Emma; Lewis, Steff C.

In: The Lancet, Vol. 386, No. 9998, 12.09.2015, p. 1041–1048.

Research output: Contribution to journalArticle

Cunningham, S, Rodriguez, A, Adams, T, Boyd, KA, Butcher, I, Enderby, B, Maclean, M, McCormick, J, Paton, JY, Wee, F, Thomas, H, Riding, K, Turner, SW, Williams, C, McIntosh, E & Lewis, SC 2015, 'Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial', The Lancet, vol. 386, no. 9998, pp. 1041–1048. https://doi.org/10.1016/S0140-6736(15)00163-4
Cunningham S, Rodriguez A, Adams T, Boyd KA, Butcher I, Enderby B et al. Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial. The Lancet. 2015 Sep 12;386(9998):1041–1048. https://doi.org/10.1016/S0140-6736(15)00163-4
Cunningham, Steve ; Rodriguez, Aryelly ; Adams, Tim ; Boyd, Kathleen A. ; Butcher, Isabella ; Enderby, Beth ; Maclean, Morag ; McCormick, Jonathan ; Paton, James Y. ; Wee, Fiona ; Thomas, Huw ; Riding, Kay ; Turner, Steve W ; Williams, Chris ; McIntosh, Emma ; Lewis, Steff C. / Oxygen saturation targets in infants with bronchiolitis (BIDS) : a double-blind, randomised, equivalence trial. In: The Lancet. 2015 ; Vol. 386, No. 9998. pp. 1041–1048.
@article{ff77d62a605340aabd73072f2cd42040,
title = "Oxygen saturation targets in infants with bronchiolitis (BIDS): a double-blind, randomised, equivalence trial",
abstract = "Background The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90{\%} for children with bronchiolitis, which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections. No evidence exists to support this threshold. We aimed to assess whether the 90{\%} or higher target for management of oxygen supplementation was equivalent to a normoxic 94{\%} or higher target for infants admitted to hospital with viral bronchiolitis. Methods We did a parallel-group, randomised, controlled, equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK (the Bronchiolitis of Infancy Discharge Study [BIDS]). A central computer randomly allocated (1:1) infants, in varying length blocks of four and six and without stratification, to be clipped to standard oximeters (patients treated with oxygen if pulse oxygen saturation [SpO2] <94{\%}) or modified oximeters (displayed a measured value of 90{\%} as 94{\%}, therefore oxygen not given until SpO2 <90{\%}). All parents, clinical staff, and outcome assessors were masked to allocation. The primary outcome was time to resolution of cough (prespecified equivalence limits of plus or minus 2 days) in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN28405428. Findings Between Oct 3, and March 30, 2012, and Oct 1, and March 29, 2013, we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters. Cough resolved by 15·0 days (median) in both groups (95{\%} CI for difference −1 to 2) and so oxygen thresholds were equivalent. We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group. In the standard care group, eight infants transferred to a high-dependency unit, 23 were readmitted, and one had a prolonged hospital stay. In the modified care group, 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital. Recorded adverse events did not differ significantly. Interpretation Management of infants with bronchiolitis to an oxygen saturation target of 90{\%} or higher is as safe and clinically effective as one of 94{\%} or higher. Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children, particularly in developing nations where resources are scarce. Funding National Institute for Health Research, Health Technology Assessment programme.",
keywords = "bronchiolitis, oxygen saturation, respiratory infection , hypoxemia, respiratory syncytial virus",
author = "Steve Cunningham and Aryelly Rodriguez and Tim Adams and Boyd, {Kathleen A.} and Isabella Butcher and Beth Enderby and Morag Maclean and Jonathan McCormick and Paton, {James Y.} and Fiona Wee and Huw Thomas and Kay Riding and Turner, {Steve W} and Chris Williams and Emma McIntosh and Lewis, {Steff C}",
note = "National Institute for Health Research, Health Technology Assessment programme (project number 09/91/16). Trial registration: ISRCTN28405428 Open access funded by Department of Health UK",
year = "2015",
month = "9",
day = "12",
doi = "10.1016/S0140-6736(15)00163-4",
language = "English",
volume = "386",
pages = "1041–1048",
journal = "The Lancet",
issn = "0140-6736",
publisher = "ACADEMIC PRESS INC ELSEVIER SCIENCE",
number = "9998",

}

TY - JOUR

T1 - Oxygen saturation targets in infants with bronchiolitis (BIDS)

T2 - a double-blind, randomised, equivalence trial

AU - Cunningham, Steve

AU - Rodriguez, Aryelly

AU - Adams, Tim

AU - Boyd, Kathleen A.

AU - Butcher, Isabella

AU - Enderby, Beth

AU - Maclean, Morag

AU - McCormick, Jonathan

AU - Paton, James Y.

AU - Wee, Fiona

AU - Thomas, Huw

AU - Riding, Kay

AU - Turner, Steve W

AU - Williams, Chris

AU - McIntosh, Emma

AU - Lewis, Steff C

N1 - National Institute for Health Research, Health Technology Assessment programme (project number 09/91/16). Trial registration: ISRCTN28405428 Open access funded by Department of Health UK

PY - 2015/9/12

Y1 - 2015/9/12

N2 - Background The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90% for children with bronchiolitis, which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections. No evidence exists to support this threshold. We aimed to assess whether the 90% or higher target for management of oxygen supplementation was equivalent to a normoxic 94% or higher target for infants admitted to hospital with viral bronchiolitis. Methods We did a parallel-group, randomised, controlled, equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK (the Bronchiolitis of Infancy Discharge Study [BIDS]). A central computer randomly allocated (1:1) infants, in varying length blocks of four and six and without stratification, to be clipped to standard oximeters (patients treated with oxygen if pulse oxygen saturation [SpO2] <94%) or modified oximeters (displayed a measured value of 90% as 94%, therefore oxygen not given until SpO2 <90%). All parents, clinical staff, and outcome assessors were masked to allocation. The primary outcome was time to resolution of cough (prespecified equivalence limits of plus or minus 2 days) in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN28405428. Findings Between Oct 3, and March 30, 2012, and Oct 1, and March 29, 2013, we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters. Cough resolved by 15·0 days (median) in both groups (95% CI for difference −1 to 2) and so oxygen thresholds were equivalent. We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group. In the standard care group, eight infants transferred to a high-dependency unit, 23 were readmitted, and one had a prolonged hospital stay. In the modified care group, 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital. Recorded adverse events did not differ significantly. Interpretation Management of infants with bronchiolitis to an oxygen saturation target of 90% or higher is as safe and clinically effective as one of 94% or higher. Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children, particularly in developing nations where resources are scarce. Funding National Institute for Health Research, Health Technology Assessment programme.

AB - Background The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90% for children with bronchiolitis, which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections. No evidence exists to support this threshold. We aimed to assess whether the 90% or higher target for management of oxygen supplementation was equivalent to a normoxic 94% or higher target for infants admitted to hospital with viral bronchiolitis. Methods We did a parallel-group, randomised, controlled, equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK (the Bronchiolitis of Infancy Discharge Study [BIDS]). A central computer randomly allocated (1:1) infants, in varying length blocks of four and six and without stratification, to be clipped to standard oximeters (patients treated with oxygen if pulse oxygen saturation [SpO2] <94%) or modified oximeters (displayed a measured value of 90% as 94%, therefore oxygen not given until SpO2 <90%). All parents, clinical staff, and outcome assessors were masked to allocation. The primary outcome was time to resolution of cough (prespecified equivalence limits of plus or minus 2 days) in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN28405428. Findings Between Oct 3, and March 30, 2012, and Oct 1, and March 29, 2013, we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters. Cough resolved by 15·0 days (median) in both groups (95% CI for difference −1 to 2) and so oxygen thresholds were equivalent. We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group. In the standard care group, eight infants transferred to a high-dependency unit, 23 were readmitted, and one had a prolonged hospital stay. In the modified care group, 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital. Recorded adverse events did not differ significantly. Interpretation Management of infants with bronchiolitis to an oxygen saturation target of 90% or higher is as safe and clinically effective as one of 94% or higher. Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children, particularly in developing nations where resources are scarce. Funding National Institute for Health Research, Health Technology Assessment programme.

KW - bronchiolitis

KW - oxygen saturation

KW - respiratory infection

KW - hypoxemia

KW - respiratory syncytial virus

U2 - 10.1016/S0140-6736(15)00163-4

DO - 10.1016/S0140-6736(15)00163-4

M3 - Article

VL - 386

SP - 1041

EP - 1048

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9998

ER -